BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREGA TABS

    MDR report key: 11189250 · Received January 18, 2021

    Report

    Report Number
    1020379-2021-00004
    Event Type
    Injury
    Date Received
    January 18, 2021
    Report Date
    January 9, 2021
    Manufacturer
    BLOCK DRUG CO., INC.
    Product Code
    EFT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE: (B)(4).

    Description of Event or Problem · 1

    HE HAD MISTAKEN THE CLEANING TABS WITH THE SONRISAL AND HE TOOK A CUP FULL WITH THE COREGA TABS TABLETS [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A MALE PATIENT WHO RECEIVED DENTURE CLEANSER (COREGA TABS) TABLET FOR PRODUCT USED FOR UNKNOWN INDICATION. CO-SUSPECT PRODUCTS INCLUDED ASPIRIN, SODIUM CARBONATE, SODIUM BICARBONATE, CITRIC ACID (SONRISAL) UNKNOWN FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA TABS AT AN UNKNOWN DOSE AND FREQUENCY AND SONRISAL AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA TABS AND SONRISAL, THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND PRODUCT CONFUSION. THE ACTION TAKEN WITH COREGA TABS WAS UNKNOWN. THE ACTION TAKEN WITH SONRISAL WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION AND PRODUCT CONFUSION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO COREGA TABS. ADDITIONAL DETAILS: THIS CASE WAS REPORTED BY A CONSUMER. IT WAS REPORTED THAT THE CONSUMER'S HUSBAND DID NOT READ THE PACKAGE AND HE HAD MISTAKEN THE CLEANING TABS WITH THE SONRISAL AND HE TOOK A CUP FULL WITH THE COREGA TABS TABLETS. THE CONSUMER WANTED TO KNOW ABOUT THE CHEMICAL PRODUCTS AND WHAT COULD CAUSE IN THE ORGANISM. SOURCE METHOD WAS EMAIL. CONSUMER TREATED BY AN HCP (HEALTHCARE PROFESSIONAL) WAS REPORTED AS NONE. REPORTER CONSENTED TO FOLLOW-UP WAS REPORTED AS NO. REPORTER'S AUTHORIZATION TO FOLLOW-UP WITH HCP WAS REPORTED AS NONE. THE SUSPECT DRUG WAS COREGA TAB UNKNOWN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84036 COREGA TABS DENTURE CLEANSER EFT BLOCK DRUG CO., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other